Stryker Disposable Bipolar Forceps Recall for Incorrect Expiration Date Labeling
Stryker Corporation recalls Disposable Spetzler-Malis Bipolar forceps due to labeling error. Products are labeled for 54-month shelf life but have actual 36-month shelf life, risking use of expired sterile surgical equipment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a labeling error on Class II medical devices involving mislabeled expiration dates (54 months stated vs. 36 months actual). Although no injuries or illnesses have been reported, this represents a risk-of-harm scenario where sterile surgical instruments could be used beyond their certified shelf life, potentially compromising sterility and equipment function during critical procedures.
Plain-English summary
Stryker Corporation is recalling certain Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6780-230-005, 23CM SLM DISP BAYONET 0.5MM). A total of 2,321 units have been identified as affected, with lot numbers 201015016, 201029011, and 201105009.
An error was identified on the product label regarding the expiration date. The actual shelf life is 36 months (3 years), but the product label indicates a shelf life of 54 months (4.5 years). This discrepancy could result in sterile surgical instruments being used beyond their certified shelf life.
The affected products were distributed to the United States and internationally to Australia, Canada, Japan, Korea, and Singapore. Users should verify lot numbers to determine if they possess affected inventory.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
- Manufacturer
- Stryker Corporation
- Hazard
- shelf-life-mislabeling
- sterility-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- GTIN: 7613327300307
- Lot Numbers: 201015016
- 201029011
- 201105009
Distribution
Distributed nationwide across the United States.
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